Immunovaccine Announces Financial Results for Quarter Ended March
31, 2014
HALIFAX, NOVA SCOTIA--(Marketwired - May 28, 2014) -
Immunovaccine Inc. ("Immunovaccine" or "IMV") (TSX-VENTURE:IMV), a
clinical stage vaccine company, today released its financial and
operational results for the quarter ended March 31, 2014.
"Since the beginning of 2014, Immunovaccine has made important
strides in advancing its DepoVax™ adjuvanting platform for the
development of novel vaccines for cancer and infectious disease
indications," said Dr Marc Mansour, chief operating officer of
Immunovaccine. "A new collaboration with the Dana-Farber Cancer
Institute, focused on HPV-related cervical and head and neck
cancers, expands our cancer vaccine clinical research. Importantly,
our work with Dana-Farber represents the first time that academic
researchers will conduct clinical studies with a novel vaccine
candidate created by combining DepoVax™ with their own
antigen."
"Our collaboration with the US National Institutes of Health
also yielded strong results in the development of a single-dose,
rapid response anthrax vaccine. Our latest anthrax challenge
studies demonstrated that a DepoVax™-enabled vaccine may provide
rapid protection using a low level of antigen," Dr. Mansour said.
"More studies will be needed but the evidence thus far suggests
that we are on the right path to providing a single-dose solution
for a possible bioterrorism application."
Highlights of the First Quarter 2014 and Subsequent to Quarter
End:
• DepoVax™ Platform - DepoVax™ was selected by the Dana-Farber
Cancer Institute as the underlying adjuvanting technology for a new
cancer vaccine that will be evaluated in a study in patients with
cervical and head and neck cancer. Dana-Farber has been awarded a
three-year, $1.2 million research grant from Stand Up To Cancer
(SU2C) and the Farrah Fawcett Foundation to fund a Phase I clinical
trial of the group's peptide cancer antigen formulated in DepoVax
in patients with HPV-related cervical and head and neck
cancers.
• Cancer Vaccines - New positive clinical data on the Company's
cancer vaccine candidate, DPX-Survivac, will be presented as a
poster at the 2014 American Society of Clinical Oncology ("ASCO")
Annual Meeting in Chicago, IL from May 30 to June 3. Results
presented from the Phase I/Ib clinical study demonstrate promising
early evidence of clinical activity for DPX-Survivac in ovarian
cancer patients, including one patient who experienced a partial
response (PR). The PR, defined as a shrinking of tumor size by at
least 30%, using Response Evaluation Criteria In Solid Tumors
(RECIST 1.1), was accompanied by reduction in levels of a commonly
used ovarian cancer biomarker (CA125) and a significant increase in
vaccine-induced immune responses.
Additionally, positive data from clinical and preclinical
vaccine studies, including DPX-Survivac, were presented at the
American Association for Cancer Research (AACR) 2014 Annual
Meeting. Results demonstrated that metronomic cyclophosphamide
(mCPA), an immune modulating agent, enhanced the immunogenicity of
DepoVax™-based vaccines in preclinical cancer models consistent
with previously reported Phase I data showing a similar enhancement
of DPX-Survivac in patients. Importantly, the animal studies
demonstrated the combination therapy's ability to eliminate
advanced tumors that could not be treated with vaccine or mCPA
alone. The addition of anti-PD-1 checkpoint inhibitor to the
DepoVax vaccine/mCPA combination resulted in further enhanced
anti-tumor activity, which allowed the treatment of more advanced
tumors. The effective tumor regressions that were observed could
not be achieved without the use of vaccine and the use of
anti-PD-1.
• Infectious Diseases - Immunovaccine announced positive results
from anthrax challenge studies showing that rabbits administered a
vaccine containing mutant recombinant Protective Antigen (mrPA)
formulated in DepoVax were protected against a lethal anthrax
challenge at a range of antigen doses. All animals vaccinated with
a single dose of mrPA - DepoVax™ containing as little as one third
of a microgram of antigen were protected from anthrax infection.
Four out of five animals vaccinated with mrPA - DepoVax™ containing
one tenth of a microgram of antigen were also protected. These
findings indicated that DepoVax™ can rapidly produce protection
against anthrax with single doses of very little antigen.
• Leadership - Immunovaccine appointed Dr. Llew Keltner to its
board of directors as part of its ongoing efforts to strengthen the
leadership of the Company.
Q1 2014 Financial Results
The Company prepares its unaudited interim condensed
consolidated financial statements in accordance with Canadian
generally accepted accounting principles as set out in the Handbook
of the Canadian Institute of Chartered Accountants - Part I ("CICA
Handbook"), which incorporates International Financial Reporting
Standards ("IFRS") as issued by the International Accounting
Standards Board ("IASB").
The Company's net loss for the period increased from a loss of
$1.6 million during the quarter ended March 31, 2013 to a loss of
$1.9 million during the quarter ended March 31, 2014. This relates
mainly to a decrease of $185,000 in government loans and
assistance.
For the quarter ended March 31, 2014, the Company reported total
R&D expenses of $1,135,000, less government loans and
assistance of $152,000 and investment tax credits of $67,000. This
represented a $296,000 increase of net R&D expenses over the
three months ended March 31, 2013. G&A expenses of $684,000
were reported for Q1 Fiscal 2014 compared to $614,000 for the three
months ended March 31, 2013, an overall increase of $70,000. Total
business development expenses of $299,000 in Q1 Fiscal 2014
represented an increase of $78,000 compared to the three months
ended March 31, 2013.
At March 31, 2014, Immunovaccine had cash and cash equivalents
of $2.0 million and working capital of $1.9 million as compared to
$3.5 million in cash and $3.3 million in working capital at
December 31, 2013.
As of March 31, 2014, the number of issued and outstanding
common shares was 79,550,642. On March 31, 2014, the number of
stock options outstanding was 5,217,835 and the number of
outstanding warrants was 31,325.
Immunovaccine's unaudited interim condensed consolidated
financial statements for March 31, 2014, filed in accordance with
IFRS, and the management discussion and analysis (MD&A), are
available at www.sedar.com.
About Immunovaccine
Immunovaccine Inc. develops cancer immunotherapies and
infectious disease vaccines based on the Company's DepoVax™
platform, a patented formulation that provides controlled and
prolonged exposure of antigens and adjuvants to the immune system.
Immunovaccine has advanced two T cell activation therapies for
cancer through Phase I human clinical trials. Lead cancer vaccine
therapy, DPX-Survivac, is expected to enter Phase II clinical
studies in 2014, in ovarian cancer and glioblastoma (brain cancer).
The Company is also advancing an infectious disease pipeline
including innovative vaccines for respiratory syncytial virus (RSV)
and anthrax.
This press release contains forward-looking information
under applicable securities law. All information that addresses
activities or developments that we expect to occur in the future,
is forward-looking information. Forward-looking statements are
based on the estimates and opinions of management on the date the
statements are made. However, they should not be regarded as a
representation that any of the plans will be achieved. Actual
results may differ materially from those set forth in this press
release due to risks affecting the company, including access to
capital, the successful completion of clinical trials and receipt
of all regulatory approvals. Immunovaccine Inc. assumes no
responsibility to update forward-looking statements in this press
release except as required by law.
Neither TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in the policies of the TSX
Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release.
Immunovaccine Inc.Kimberly Stephens(902)
492-1819kstephens@imvaccine.comwww.imvaccine.comVida Strategic
Partners (media)Tim Brons(415) 675-7402tbrons@vidasp.com
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